A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

NCT ID: NCT04111341

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-06
• Study Completion Date: 2017-12-31

Brief Summary

To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

Detailed Description

This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.

Conditions

Sjögren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

TCM Gan-Lu-Yin (GLY)

TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks

Group Type: EXPERIMENTAL

TCM (Gan-Lu-Yin)GLY

Intervention Type: DRUG

TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks

PLACEBO

TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Interventions

TCM (Gan-Lu-Yin)GLY

TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks

Intervention Type: DRUG

PLACEBO

TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Gan-Lu-Yin

Eligibility Criteria

Inclusion Criteria

• Age ≥20 years old
• Written informed consent obtained
• Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
• The ESSPRI score of the patient of Sjogren's syndrome at least> 3

Exclusion Criteria

• Have association disease about heart, lung, nerve or mental
• Pregnant or breastfeeding women
• Laboratory abnormality:

1. Serum creatinine ≥2.0 mg/dl

2. Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl

3. Neutrophil or lymphocyte<0.5 x 109/l

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Chung Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei C- C, M

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Chung Shan Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CS16051

Identifier Type: -

Identifier Source: org_study_id